More than two years after the Food and Drug Administration first said it would propose rules on regulating electronic cigarettes, the agency still hasn't taken action. In the meantime, the number of people using e-cigarettes—which deliver a vaporized form of nicotine via liquid cartridges heated by a battery—has skyrocketed: U.S. sales are projected to reach $1.5 billion in 2013, triple the amount from 2012.
There are other signs of e-cig's growing popularity. Celebrities are now showing up in e-cigarette ads. And more than 100 companies are vying for a share of the skyrocketing e-cig market. Perhaps most tellingly, Big Tobacco is getting into the game, either buying smaller e-cigarette companies or creating their own offshoots, like Philip Morris’s MarkTen and RJ Reynolds’s Vuse.
So why is it taking the FDA so long? Several reasons.
The FDA had set a target date of October 2013 to release its proposed rules to the public. But the partial government shutdown in late September and early October likely delayed the process. The agency did get a proposed rule sent in mid-October to the federal Office of Management and Budget, which will review the rule before it's released for public comment.
The specifics of the rule are mere speculation at this point, but at the very least the agency is expected to redefine “tobacco product” to include e-cigarettes, thus bringing them under the same federal oversight that applies to cigarettes, cigarette tobacco, chewing tobacco, and roll-your-own tobacco. That could subject the gadgets to the same requirements for ingredient disclosure, manufacturing quality, and restrictions on sale to minors that apply to conventional tobacco products.
Less clear is whether the agency will take aim at the kid-friendly flavors e-cigarettes come in, such as bubblegum and watermelon, or move to curtail Internet sales, which make age verification almost impossible. (On the website of market leader Blu e-Cigs, for example, all you need to enter the site and buy e-cigarettes is to click a box that says “18+.”) It’s also up in the air how the FDA will address the advertising of e-cigarettes, and whether it will weigh in on whether they should be banned indoors.
E-cigarettes’ visibility and appeal to kids has been an extra-hot topic since the Centers for Disease Control and Prevention released data this year showing that use among high-school and middle-school students doubled from 2011 to 2012, with an estimated 1.8 million students now saying they’ve tried the devices. In a letter dated Sept. 24, 2013, the attorneys general of 37 states urged the FDA to impose on e-cigarette makers the same restrictions on marketing and advertising to youth that already apply to conventional cigarettes, citing e-cigs’ fruit and candy flavors and the use of cartoon characters in some brands’ advertisements as clear enticements to youth—and pointing out that their safety remains unknown. Restrictions are necessary “to safeguard children from nicotine addiction and other potential health effects of e-cigarettes,” the AGs wrote.
In the meantime, the European Parliament recently scrapped a proposal by health officials to tighten regulations on e-cigarettes by reclassifying them as medical devices, which would have subjected them to the same onerous and potentially expensive approval process required for drugs. Instead, the body opted to regulate them in the same manner as traditional tobacco products, as the FDA is expected to do.
See which states and municipalities have enacted bans on e-cigarettes. (The list is maintained by Americans for Nonsmokers’ Rights, a group that opposes electronic cigarettes.)
—Jamie Kopf
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